Ins and Outs of Conducting Clinical Trials in the Asia Pacific Region

There is growing interest by life-sciences companies to conduct clinical trials in the Asia Pacific region. The Asia Pacific region offers multinational companies many benefits when it comes to conducting clinical trials. Chief among them is access to a large population of patients.

The cost to conduct clinical trials in Asia Pacific countries, except for Japan, is often less than in the US and Europe, and patient enrollment is often achieved more quickly, thus reducing the time needed to conduct the trial. Additionally, many Asia Pacific countries have rapidly growing aging populations with needs for traditional and new therapies and devices. In order to obtain regulatory approval for new drugs and medical devices, many Asia Pacific countries, such as Japan, Korea, and Taiwan, require clinical trial data obtained from Asian subjects.

While there is strong interest in conducting clinical trials in Asia Pacific countries, such studies may present a challenge in that many Asia Pacific countries do not recognize and follow International Conference on Harmonization/Good Clinical Practice (ICH/GCP) guidelines. This could be a significant hurdle for countries wanting to obtain clinical trial data that can be used in regulatory filings in the US.

Close Up: Conducting Clinical Trials in Japan

With an improved clinical trial infrastructure, Japan offers an advantageous development environment for pharmaceutical, biotechnology, and medical device companies. To address a downward trend in trial applications and a lag in the availability of drugs within the country as compared to other developed nations, Japan’s Ministry of Health, Labor and Welfare (MHLW) ushered in significant changes. These changes included creating a more welcoming and efficient approach to trials, new consultation systems, and offering new subsidies to lower the regulatory and clinical cost for expedited review while maintaining global standards such as the ICH-GCP.

Clinical trials in Japan enroll patients very quickly. In fact Japan is the fastest country for patient enrollment in the Asia Pacific region. At the same time, Japan is the most expensive Asia Pacific country to conduct clinical trials in.

Determining whether or not to conduct clinical trials in an Asia Pacific country

If you are considering conducting clinical trials in an Asia Pacific country, consider engaging a partner that has an operating office and has experience in the region. Benefits of engaging a local, experienced, and qualified partner in the Asia Pacific region are:

Knowledge of local investigative sites – The partner can assist in evaluating study sites and determining whether or not the site is able to follow ICH/GCP guidelines and report protocol violations and deviations in an appropriate and timely manner.

Knowledge of local regulations – Regulations in the Asia Pacific region are changing rapidly, and it’s much easier to stay on top of these changes if the partner lives in the region.

Knowledge of local regulatory guidelines – It is best to have local personnel meet face-to-face with regulatory authorities prior to planning a study and throughout the study’s life cycle.

Knowledge of local cultural customs and language -The Asia Pacific region is large and culturally diverse. Partners need to understand local cultural norms and communicate in various languages.

Why Clinlogix?

Clinlogix has people and resources in the Asia Pacific region with a strong background in jGCP guidelines (Japan-only studies) and with knowledge of local regulations. This means that we can successfully execute an efficient regulatory and/or clinical project in the region. We maintain long-term relationships with an important network of clinical sites, which helps speed up study enrollment. With the increase in combination products that include both a therapeutic “drug” and medical product, it’s beneficial to have a partner on your team that has extensive experience in both areas.

For multinational programs, we can have agreement to follow GCP. It is a negotiation with each site during the SQV visit and reinforced at the SIV visits. It takes time and patience to establish trust and a working relationship with the sites. Once all this is accomplished, then enrollment can be fast.

We’d love to hear from you! Please share your thoughts on and experiences in conducting clinical trials in the Asia Pacific region.